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510(k) K942234

VISITEC PRECISE-POINT by Visitec Co. — Product Code GAP

K942234 is an FDA 510(k) premarket notification submitted by Visitec Co. for the device "VISITEC PRECISE-POINT". The FDA issued a decision of Substantially Equivalent on July 12, 1994. The device falls under product code GAP (Suture, Nonabsorbable, Silk), a Class II device regulated under 21 CFR 878.5030. Visitec Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 12, 1994
Date Received
May 9, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Suture, Nonabsorbable, Silk
Device Class
Class II
Regulation Number
878.5030
Review Panel
SU
Submission Type

Other clearances by Visitec Co.

  • K953394 — VISITEC COLLAR BUTTON CATHETER {GRIFFITHS} (October 12, 1995)
  • K945114 — VISITEC SCLERAL PLUG (February 23, 1995)
  • K945738 — VISIFLEX OPHTHALMIC SURGICAL INCISE DRAPE (February 14, 1995)
  • K945172 — VISITEC SILICONE RETINAL IMPLANTS/EXPLANTS (January 17, 1995)
  • K934269 — FIBEROPTIC ILLUMINATED INSTRUMENTS (May 17, 1994)
  • K940210 — VISITEC EYE PAD (March 7, 1994)
  • K933872 — VISI-SPEAR EYE SPONGE (December 27, 1993)
  • K923972 — OPHTHALMIC FLUID DISTRIBUTION SETS (November 4, 1992)
  • K922530 — VISITEC MICROSURGICAL SUTURE (October 20, 1992)
  • K923645 — VISITEC ASPIRATING SYRINGE (September 30, 1992)

Other clearances for product code GAP

  • K241486 — Sofsilk™ Coated Braided Silk Suture (December 3, 2024)
  • K222944 — SafePath Sulturing System-Silk Suture, SafePath Sulturing System Polyamide Sutur (October 18, 2024)
  • K232355 — Non absorbable Surgical Silk Suture (January 16, 2024)
  • K221767 — Surgical Sutures with or without Needle (July 31, 2023)
  • K180701 — SafePath Suturing System (June 25, 2018)
  • K172149 — FILASILK - Natural Non-absorbable Silk Surgical Suture, FILAMIDE - Non Absorbabl (October 20, 2017)
  • K162396 — SILK Surgical Suture (November 23, 2016)
  • K160623 — FILASILK - Natural Non-absorbable Silk Surgical Suture, FILAMIDE - Non Absorbabl (May 31, 2016)
  • K080684 — WG-SURGICAL SUTURES WITH NEEDLE (June 9, 2008)
  • K071111 — NON-ABSORBABLE SILK SUTURE (July 17, 2007)

FDA data resources